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Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections Clinical research trials and Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections. Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections clinical trial. Participants oftentimes recieve the most expert healthcare available for their Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections  Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections
Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections
For Condition: Mycoses
Status: Recruiting
Sponsor(s): Schering-Plough ,
Synopsis: This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A. which are refractory or resistant to standard antifungal therapies; B. for which there are currently no effective therapies; C. with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.
Details: The current clinical trial is designed to provide posaconazole (SCH 56592 to subjects with invasive fungal infections a) which are refractory or resistant to standard antifungal therapies or b) for which there are currently no effective therapies. Subjects with such invasive fungal infections cannot be enrolled in controlled, randomized clinical trials. Secondly, this clinical trial is also designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections who c) have experienced serious or severe toxicities while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy. This clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole (SCH 56592) against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial. This is an open-label, treatment protocol for a multi-center study of posaconazole (SCH 56592) 200mg orally four times daily (QID) while hospitalized followed by posaconazole (SCH 56592) 400mg orally twice daily (BID) on discharge from hospital, in the treatment of invasive fungal infections. Approximately 45 subjects have been enrolled at 25 clinical study centers in the US and worldwide.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Proven or probable invasive fungal infections according to EORTC/MSG criteria. - IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy. - Able to take oral medication or take medication via enteral feeding tube. Exclusion Criteria: - History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals. - Concurrent progressive neurological disease (except if due to invasive fungal infection) - Use of medications that are known to interact with azoles and that may lead to life-threatening side effects: terfenadine, cisapride, ebastine at entry or within 24 hours prior to therapy, or astemizole at entry or within 10 days prior to entry.concentration/efficacy of azole antifungals: rifampin, carbamazepine.
Total Enrollment:
Location and Contact Information:
University of Cincinnati, College of Medicine *Recruiting*
Cincinnati, Ohio, 45267-0558
United States
Recruiting Joseph Solomkin 513-558-4427
University of Kentucky Med. Ctr. *Recruiting*
Lexington, Kentucky, 40536
United States
Recruiting Richard Greenberg 859-323-6892
Hopital De La Conception *Recruiting*
Marseille, ,
France
Recruiting Herve Gallais 04-91-38-35-31
Corporation Para Investigaciones Biologicas CIB *Recruiting*
Medellin, ,
Colombia
Recruiting Angela Restrepo 57-4-4415514
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting John Perfect 919-681-6793
Royal University Hospital *Recruiting*
Saskatoon, , S7N 0W8
Canada
Recruiting Stephen Sanche 306-655-1777
A.P.H. Paris *Recruiting*
Creteil Cedex, ,
France
Recruiting Catherine Cordonnier 01.49.81.20.59
Emory Clinic *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Amelia Langston 404-778-5714
Eastern Maine Medical Center *Recruiting*
Bangor, Maine, 04401-6612
United States
Recruiting Robert Pinsky 207-973-5810
Blood and Marrow Transplant Group of Georgia *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Lawrence Morris 404-255-1930
Dwight David Eisenhower Army Medical Center *Recruiting*
Fort Gordon, Georgia, 30905-5650
United States
Recruiting Josephine Skidmore 706-787-6492
William Beaumont Hospital *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting Marcus Zervos 248-551-6059
Centro de Investigaciones Medicas Asociadas *Recruiting*
Hermosillo, ,
Mexico
Recruiting Rodrigo Sanchez-Lopez 62-14-2477
The Children's Hospital *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Mark Abzug 303-861-6389
Universitaet Koeln *Recruiting*
Koeln, , 50931
Germany
Recruiting Oliver Cornely 49-221-478-6209
Carilion Infectious Disease *Recruiting*
Roanoke, Virginia, 24016
United States
Recruiting Jean Smith 540-981-7715
Hopital De Hautepierre *Recruiting*
Strasbourg Cedex, ,
France
Recruiting Raoul Herbrecht 03-88-12-81-48
University of Texas MDAnderson Cancer Center *Recruiting*
Houston, Texas,
United States
Recruiting Issam Raad 713-792-7943
Nemour's Children's Clinic *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Eric Sandler 904-390-3793
Bringham & Women's Hopsital *Recruiting*
Boston, Massachusetts,
United States
Recruiting Lindsey Baden 617-732-8110
Children's Medical Center *Recruiting*
Dayton, Ohio, 45404
United States
Recruiting Sherman Alter 937-641-3329
Hospital Saint Louis *Recruiting*
Paris, ,
France
Recruiting Eliane Gluckman 01-42-49-96-39
University of Miami School *Recruiting*
Miami, Florida, 33136
United States
Recruiting Delia Rivera 305-243-2756
Kern Medical Center *Recruiting*
Bakersfield, California,
United States
Recruiting Royce Johnson 661-326-2224
University of Nebraska *Recruiting*
Omaha, Nebraska,
United States
Recruiting Stefano Tarantolo 406-329-7005
Hospital Universitario "DR. J.E. Gonzalez" *Recruiting*
Monterrey, ,
Mexico
Recruiting Adrian Perez 01-81-8333-83-81
Hospital Nacional Cayetano Heredia *Recruiting*
San Martin de Porres, ,
Peru
Recruiting Ana Bustamante 511 319000
Hendrick Medical Center *Recruiting*
Abilene, Texas,
United States
Recruiting John Gullett 915-670-4570
Klinikum der Johannes Gutenberg-Universitaet Mainz *Recruiting*
Mainz, ,
Germany
Recruiting Andrew Ullmann 49 6131 17 6564
Loma Linda University *Recruiting*
Loma Linda, California, 92354
United States
Recruiting Albert Kheradpour 909-558-8407
Klinikum der Ludewig Maximillians, Univ. Muenchen *Recruiting*
Muenchen, ,
Germany
Recruiting Xaver Schiel 49-89-70950
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195-5032
United States
Recruiting Steven LaRosa 216-445-2420
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Wong 617-632-0760
The Children's Mercy Hospital Center *Recruiting*
Kansas City, Missouri,
United States
Recruiting Andrew Gilman 816-234-3265
The Univerity of Iowa *Recruiting*
Iowa City, Iowa, 52242
United States
Recruiting Rachel Miller 319-356-3674
University of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Jo-Ann Burik 612-273-6212
Instituto Nacional Do Cancer *Recruiting*
Rio de Janiero, ,
Brazil
Recruiting Marcelo Schirmer 5521-22174214
Rush Presbyterian St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Laurie Proia 312-942-5865
Emory University *Recruiting*
Atlanta, Georgia,
United States
Recruiting Amelia Langston 404-778-4189
Hospital De Infectologia, Centro Medico Nacional "La Raza" IMASS *Recruiting*
Mexico, D.F., ,
Mexico
Recruiting Veronica Flores 525-583-22-11
Naval Medical Center San Diego *Recruiting*
San Diego, California,
United States
Recruiting Braden Hale 619-532-7475
The Children's Hopsital *Recruiting*
Denver, Colorado,
United States
Recruiting Mark Abzug 303-861-6389
Cleveland Clinic Foundation Infectious Disease *Recruiting*
Cleveland, Ohio,
United States
Recruiting Steven Larosa 216-444-5519
Harbor-UCLA Research and Education Institute *Recruiting*
Torrance, California, 90502
United States
Recruiting John Edwards 310-333-3813
New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Susan Hadley 617-636-3099
University of Texas Health Sciences Center *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Richard Graybill 210-617-5111
Hospital Das Clinicas Da FMUSP *Recruiting*
Sao Paulo - SP, ,
Brazil
Recruiting Maria Yasuda 5511-3061-5544
Instituto Nacional Do Cancer Corporaction para Investigaciones *Recruiting*
Rio de Janeiro, ,
Brazil
Recruiting Marcelo Schirmer 5521-221-74214
Methodist Hospital German *Recruiting*
Germantown, Tennessee, 38138
United States
Recruiting Stephen Threlkeld 901-55-5200
Institut Jules Bordet *Recruiting*
Brussels, ,
Belgium
Recruiting Mickael Aoun 32 2 541 37 09
Basel Kantonsspital *Recruiting*
Basel, ,
Switzerland
Recruiting Basel Kantonsspital
Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Kathleen Mullane 708-216-8777
C.H.U. de Strasbourg, Hopital de Hautepierre *Recruiting*
Strasbourg, ,
France
Recruiting Raoul Herbrecht 03-88-12-8148
Hospital Francisco J Muniz *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Ricardo Negroni 54 11 4304 4655
National Institute of Health *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Steven Holland 301-496-1211
University of Florida - College of Medicine *Recruiting*
Gainesville, Florida, 32610
United States
Recruiting Minh-Hong Nguyen 352-379-4027
Texas Tech University *Recruiting*
Odessa, Texas, 79763
United States
Recruiting Karlene Reid 915-335-5250
Hopital Maisonneuve-Rosemont *Not yet recruiting*
Montreal, ,
Canada
Not yet recruiting Michael Laverdiere 514 252 3817
Childrens Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027
United States
Recruiting Jill Hoffman 323-669-2509
Memorial Sloan Kettering Infectious Disease *Recruiting*
New York City, New York, 10021
United States
Recruiting Josephine Seo 212-639-7810
UCSD Medical Center *Recruiting*
San Diego, California, 92103
United States
Recruiting Antonino Catanzaro 619-543-6222
The Queen's Physicians *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting William Lau 808-532-2955
Brigham & Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lindsey Baden 619-532-6131
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105
United States
Recruiting Katherine Knapp 901-495-3252
University Of Cape Town, Dept Of Hematology *Recruiting*
Cape Town, ,
South Africa
Recruiting Nicolas Novitzky 27-21-404-3073
Royal University Hospital *Not yet recruiting*
Saskatoon, ,
Canada
Not yet recruiting Stephen Sanche 306-655-1777
Additional Information:
Study ID Numbers: P02095; yes
Study Start Date: September 2001
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034632
Other Mycoses Studies:
1. An Open Label, Non-comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
2. Voriconazole to Prevent Systemic Fungal Infections in Children
3. Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
4. Voriconazole to Treat Fungal Infections
5. Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
Related Studies:
Other Mycoses Clinical Trials
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Other Gainesville Clinical Trials
Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections
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